Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-24 @ 10:34 PM
NCT ID:
NCT03660735
Eligibility Criteria:
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Female, aged 18 years to 39 years at the time of egg collection.
* Participant has an ovulatory cycle of 25-35 days.
* Participant is undergoing:
* A first or second cycle of IVF and ICSI for male factor subfertility, or
* An IVF cycle to treat subfertility with a history of RIF, or
* An IVF cycle to treat at least 1 year of subfertility
We do not plan to target specific numbers in each group. Rather, the numbers that recruit in each group will be assessed at the end of the study and may well influence the design of the main study.
Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
* Donor egg cycle.
* Age 40 or above at the time of egg collection.
* Ovulatory cycle of \<25 or \>35 days or evidence of anovulation
* Involved in a interventional research study of any medication that may have an effect on the immune system
* Patient taking oral steroids or other immunomodulatory medication
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT03660735
Study Brief:
Protocol Section:
NCT03660735